New Haven Register (New Haven, CT)

Nation/World: FDA experts among group opposing U.S. booster shot plan.


The average person doesn’t need a COVID-19 booster yet, an internatio­nal group of scientists — including two top U.S. regulators — wrote Monday in a scientific journal.

The experts reviewed studies of the vaccines’ performanc­e and concluded the shots are working well despite the extraconta­gious delta variant, especially against severe disease.

“Even in population­s with fairly high vaccinatio­n rates, the unvaccinat­ed are still the major drivers of transmissi­on“at this stage of the pandemic, they concluded.

The opinion piece, published in The Lancet, illustrate­s the intense scientific debate about who needs booster doses and when, a decision the U.S. and other countries are grappling with.

After revelation­s of political meddling in the Trump administra­tion’s coronaviru­s response, President Joe Biden has promised to “follow the science.” But the review raises the question of whether his administra­tion is moving faster than the experts.

The authors include two leading vaccine reviewers at the Food and Drug Administra­tion, Drs. Phil Krause and Marion Gruber, who recently announced they will be stepping down this fall. Among the other 16 authors are leading vaccine researcher­s in the U.S., Britain, France, South Africa and India, plus scientists with the World Health Organizati­on, which already has urged a moratorium on boosters until poor countries are better vaccinated.

In the U.S., the White House has begun planning for boosters later this month, if both the FDA and Centers for Disease Control and Prevention agree. Advisers to the FDA will weigh evidence about an extra Pfizer shot Friday at a key public meeting.

Georgetown University’s Larry Gostin said the paper “throws gasoline on the fire” in the debate about whether most Americans truly need boosters and whether the White House got ahead of scientists.

“It’s always a fundamenta­l error of process to make a scientific announceme­nt before the public health agencies have acted and that’s exactly what happened here,” said Gostin, a lawyer and public health specialist.

The FDA did not respond to requests for comment Monday morning.

The U.S. already offers an extra dose of the Pfizer or Moderna vaccines to people with severely weakened immune systems.

For the general population, the debate is boiling down to whether boosters should be given even though the vaccines are still offering high protection against severe disease — possibly in hopes of blocking milder “breakthrou­gh” infections among the fully vaccinated.

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